CTRI/2019/05/019277已完成未知
A Randomized, Double-Blind, Multicentric, Parallel group, comparative clinical study of Permethrin 5% cream of Morningside Healthcare Limited, UK (Test) vs Permethrin 5% cream of Medgenix Benelux NV (Belgium) (Reference) for the treatment of scabies
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Subject is in good general health with normal appearing skin in non infected areas.
- •2.Subject is in good general health with normal appearing skin in non infected areas.
- •3.Clinical findings typical of scabies (burrows, erythematous papules, etc.) and microscopic confirmation of scabies mite, ova, or mite feces at classical sites.
- •4.Subject is able to provide written informed consent prior to study.
- •5.Willingness to comply with the study schedule and procedures.
排除标准
- •1.Subjects with any condition which in opinion of the investigator makes the subject unsuitable for inclusion.
- •2.Skin conditions that could make it difficult to evaluate the extent of an infestation or would present a problem in the evaluation of response to therapy (e.g. atopic dermatitis, eczema, contact dermatitis, lichen planus, papular urticaria, seborrheic dermatitis).
- •3.Subjects used following within 4 weeks of baseline visit 1 immunomodulators 2 systemic medications that suppress the immune system 3 topical or oral parasiticides.
- •4.Subject used following within 2 weeks of baseline visit (1) topical steroids (2) topical or systemic antibiotics.
- •5.Subject has crusted scabies.
- •6.Subject with known history of irritation or sensitivity to parasiticides.
- •7.Known allergy or hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, plants in the Asteraceae/Compositae family (e.g. chrysanthemums, ragweed, marigolds, and daisies).
- •8.Subjects whose household members and close contacts refuse treatment.
- •9.Subjects whose sexual contacts do not agree to restrict prolonged skin to skin contact with non-household members during the study period.
- •10.Subjects with a household member less than 2 months of age.
- •11.Subject with signs of systemic infection or is receiving systemic therapy for an infectious disease.
- •12.Subjects with secondary bacterial infection based on subjective evidence.
- •13.Subjects with skin wounds, open injuries or other conditions of broken skin at the site of proposed application.
- •14.Subjects with history of severe cardiac, central nervous system, immunodeficiency, diabetes mellitus, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
- •15.Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
- •16.Participation in any other clinical trial during last 30 days.
研究者
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